Laser Acupuncture for Idiopathic Bell's Palsy: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 360
- Locations
- 1
- Primary Endpoint
- House Brackmann Grading System (HB)
Study Overview
Brief Summary
Bell's palsy is characterized by acute, unilateral onset that compromises function and esthetics, exerting a considerable impact on the social, professional, and psychological aspects of the lives of affected individuals. The objective of this study was to determine whether laser acupuncture therapy could relieve symptoms in patients with Bell's palsy.
Detailed Description
This study was randomized controlled trial including 360 patients that undergoing Bell's palsy. All the patients received oral Prednisolone. Patients were assigned to the laser acupuncture (LA) group, Sham LA group and control group, with 120 patients in each group. LA group and Sham LA group were received 4 weeks of Laser treatment (3 times per week).
Clinical outcome measure comprised the House-Brackmann grading system, Sunnybrook facial grading scale (SBFG), Facial Disability Index (FDI) and Facial Clinimetric Evaluation Scale (FaCE Scale) All the measurements were collected at the baseline, weeks 2, 4, 6, 8, 12 and 24.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients diagnosed with idiopathic Bell's Palsy 2.Patients were eligible if they were graded at House-Brackmann grade (HB) 3 or higher.
Exclusion Criteria
- •Serious mental illness or social problems, and neurological disorders, and systemic diseases, such as malignant tumors, and other serious consumptive diseases.
- •Planning for pregnancy, those in pregnancy, or those who were lactating. 3.Bell's Palsy patients who have a disease course of more than 8 weeks.
Arms & Interventions
Laser acupuncture Group
Intervention: Laser acupuncture (Device)
Laser acupuncture Group
Intervention: Steroids (Drug)
Sham laser acupuncture Group
Intervention: Steroids (Drug)
Sham laser acupuncture Group
Intervention: Sham laser acupuncture (Device)
Control group
Intervention: Steroids (Drug)
Outcomes
Primary Outcomes
House Brackmann Grading System (HB)
Time Frame: Baseline, weeks 2, 4, 6, 8, 12 and 24
The HB is a physician-rated system based on criteria of resting appearance, facial movements, and synkinesis that categorizes facial function from I (normal) to VI (total paralysis), with options of "Normal", "Mild dysfunction", "Moderate dysfunction", "Moderately severe dysfunction", "Severe dysfunction" or "Total paralysis". The prognoses of grade 3 or higher were abnormal.
Secondary Outcomes
- Sunnybrook Facial Grading Scale (SB Grading)(Baseline, weeks 2, 4, 6, 8, 12 and 24)
- Facial Disability Index (FDI)(Baseline, weeks 2, 4, 6, 8, 12 and 24)
- Facial Clinimetric Evaluation Scale (FaCE Scale)(Baseline, weeks 2, 4, 6, 8, 12 and 24)